Cardiac findings signal need to revise cancer trial reporting

A team of cardio-oncologists recommended that cardiology and oncology agencies work together to define the best methods for reporting adverse cardiovascular events in chemotherapy clinical trials. Better reporting may facilitate cardiac as well as cancer drug development.

Writing in the Nov. 7 issue of the New England Journal of Medicine, John D. Groarke, MB BCh, of the cardio-oncology program at the Dana-Farber Cancer Institute at Brigham and Women’s Hospital in Boston, and colleagues noted that a number of novel therapeutics designed to treat patients with cancer have been approved or are in the development pipeline. Using chronic myeloid leukemia as an example, they discussed the evolution of treatments that raised questions about cardiovascular safety.

For instance, 24-month follow-up in a clinical trial for ponatinib (Ariad Pharmaceuticals) found that 11.8 percent of patients experienced serious thrombotic events. The FDA later reported it was investigating the frequency of adverse events such as blood clots related to use of the drug. Physicians also reported vascular events and accelerated atherosclerosis with another treatment, nilotinib.

Groarke et al wrote that as a consequence, physicians are questioning how adverse cardiovascular events are monitored and evaluated. They noted that the criteria used for reporting adverse cardiovascular events differ for cardiovascular drug trials and cancer drug trials.

Obtaining reliable data in cancer trials may require a revision of definitions and adjudication processes, they proposed. They encouraged agencies to collaborate to improve the current reporting system.

“An improved understanding of how novel targeted cancer therapies lead to cardiovascular complications could ultimately provide biologic insights into the pathophysiology of cardiovascular disease in general and, in turn, inform new platforms for cardiovascular-drug discovery,” they argued.